Often it becomes medically necessary to implant an external feeding tube (or a similar gastrostomy device) percutaneously into the gastrointestinal (“GI”) tract through the patient's abdominal wall to provide the patient nourishment when the patient cannot receive food and liquid by the normal method of oral intake. This method of nourishment may be required for patients that suffer from neurological disorders, pulmonary disease, or head, neck, or esophageal lesions. In addition, nourishment directly to the patient's GI tract through the abdomen may be required when the patient exhibits decreased gastric motility, whether because of diabetic gastropathy, scleroderma, or other causes.
Because this substitute feeding method often must be employed in a patient for extended periods of time, it is desirable to implant a percutaneous device that provides direct communication with the GI tract. After a patient receives a device to allow long term feeding directly into their GI tract, the patient can resume at least some mobility and normal activity. When the patient requires nourishment, the patient can connect a source of nourishment directly to the extended end of the device to allow the nourishment to flow directly into the patient's GI tract.
It is known in the art to use a Foley type balloon catheter as the conduit to provide nourishment directly to a patient's GI tract. As is well known, a Foley balloon catheter includes an internal lumen that extends through the length of the catheter as well as an inflatable balloon near the distal end of the catheter. Accordingly, when the balloon is not inflated, the catheter maintains a low profile for convenient insertion into a patient. After the catheter is inserted and selectively positioned, the balloon may be inflated by inserting a fluid into the balloon, which increases the profile of the catheter to prevent it from being inadvertently withdrawn from the patient. It is a known disadvantage of Foley catheters that balloons may leak or catastrophically fail, which allows the balloon to shrink and the catheter to no longer be properly positioned within the patient. Accordingly, a Foley balloon catheter is often not suitable to be used as a long term percutaneous feeding device.
Alternatively, it is also known to use a catheter with a pigtail, or similar member, at the distal end to retain the catheter within the selected position within the patient. This type of catheter must be positioned within the patient with sutures, which may become loose or slip over time if the patient is even slightly active. Additionally, it is difficult for the medical professional to determine when the pigtail, or similar member, is properly installed within the patient.
Finally, it is also known to use a malecot tube with an internal lumen within the patient to provide the path for percutaneous feeding. As is known to those of ordinary skill in the art, malecot arms are normally at substantially the same profile as the remainder of the tube and are extendable when an internal member is pulled longitudinally toward the proximal end of the malecot tube. This longitudinal relative motion compresses the malecot tube, which buckles the malecot arms outwardly because the malecot arms provide the least resistance to compression. Because the malecot tube relies on longitudinal proximal movement of an internal member that is connected with a distal end of the malecot tube, the internal member maintains a relatively high profile, or extends a significant distance out of the proximal end of the malecot tube (which extends from the patient) to operate properly. This high profile may limit the activities that a patient can perform with a malecot tube installed.
Accordingly, it is desired to provide a device for percutaneous insertion into a patient's abdomen that overcomes the drawbacks of the prior art devices. Specifically, it is desired to provide a device that is appropriate for long term use, with the state of fixation being easily viewed, and maintains a low profile when the device is installed and fixed within the patient.